Associate Director, Biostatistics

About the role

Servier, a privately‑held biopharmaceutical company in Boston, is seeking an Associate Director, Biostatistics to lead statistical strategy for one or more clinical assets. The role will partner with clinical, regulatory and evidence‑generation teams to ensure scientific rigor and regulatory relevance throughout the product lifecycle.

Key responsibilities

• Direct the execution of statistical analyses, review outputs, and ensure accurate interpretation of clinical results.
• Plan and track project timelines, justify resource needs, and manage capacity across multiple studies.
• Develop innovative study designs and decision‑making tools to support product development, medical affairs, and HEOR/HTA strategies.
• Collaborate with Biostatistics colleagues and external consultants to create effective statistical approaches and respond to regulatory inquiries.
• Prepare statistical sections of regulatory documents, including CSRs, integrated reports, and submission packages.

Required profile

• Ph.D. in Biostatistics or a related field with at least 5 years of pharmaceutical experience (or a Master’s degree with 8 years).
• Deep knowledge of advanced statistical concepts, clinical trial design, and regulatory guidance (ICH, FDA, EMEA).
• Proven ability to lead cross‑functional teams and communicate statistical findings to diverse stakeholders.

Required skills

• Proficiency in SAS for data analysis and reporting.
• Experience drafting Statistical Analysis Plans, tables, figures, and listings.
• Familiarity with regulatory submission requirements and industry standards.

What we offer

• Competitive salary range $164,000‑$194,000 plus short‑ and long‑term incentive programs.
• Comprehensive benefits including medical, dental, vision, unlimited sick/flex time, 401(k), life and disability insurance.
• Hybrid work model with occasional travel to Boston and flexibility for remote work.